Are you an experienced Regulatory Affairs professional looking to advance your career in the medical device industry? A leading healthcare company in Pune is hiring a Regulatory Affairs Specialist with expertise in US FDA (21 CFR Part 820) and EU MDR (2017/745) compliance. This role offers the chance to manage regulatory submissions, audits, product compliance, and post-market activities for Class I, II, and III devices.
🔑 Key Responsibilities
- Develop and execute regulatory strategies for Class I, II, and III medical devices.
- Prepare, review, and submit 510(k), PMA, Technical Documentation, and Design Dossiers.
- Collaborate with R&D, Quality, Clinical, and Manufacturing teams to ensure compliance throughout the product lifecycle.
- Assess regulatory impact of product/process changes and ensure proper documentation.
- Support internal and external audits including FDA inspections and Notified Body audits.
- Review and approve product labeling, IFUs, and promotional materials.
- Ensure compliance with Unique Device Identification (UDI) and support EUDAMED submissions.
- Provide oversight for post-market surveillance, vigilance reporting, and adverse event investigations.
- Liaise with regulatory authorities (FDA, Notified Bodies).
- Mentor junior team members and provide regulatory training.
🎓 Qualifications
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or related field.
- Experience: 4–8 years in Regulatory Affairs, with a strong focus on medical devices in US and EU markets.
- In-depth knowledge of US FDA regulations, EU MDR, and global regulatory frameworks.
- Strong communication, documentation, and cross-functional collaboration skills.
💼 Benefits
- Competitive salary package (₹8,00,000 – ₹16,00,000 per annum).
- Exposure to global regulatory submissions and high-impact projects.
- Professional growth with mentorship opportunities.
- Collaborative and innovation-driven work culture.
📍 Job Location
- City: Pune, India
- Designation: Associate – Regulatory Affairs Specialist